Before new drugs are allowed to be sold on the market, drug manufacturers must perform rigorous testing to show that the drugs are safe and effective. In the United States, the Food and Drug Administration (FDA) regulates such testing. In Europe, the European Union (EU) regulates such testing.
The testing of a new drug may take years before completion, may involve many people, and may generate truckloads worth of documentation. The testing generally happens over phases, with a clinical protocol being developed for each clinical trial. One of the early phases of testing, referred to as a “Phase 1” clinical trial, determines if the new drug is safe for humans. Such a Phase 1 clinical trial usually enlists several healthy volunteers to take a drug, while its effects on each volunteer is studied (e.g., vital signs may be monitored).
Before any drug is administered, a very detailed description (i.e., a clinical protocol) is developed and documented. The clinical protocol document may be reviewed by multiple levels of managers, by hospital staff, administrator, doctors, and the like. Such a review by so many parties, often causes many revisions to the clinical protocol document. Further, the clinical protocol must be approved by various people and bodies. To complicate matters further, a change in one part of the clinical protocol document, often requires revisions to multiple parts of the clinical protocol document.
For example, the clinical protocol document generally includes a chart that provides drug administration times and dosages and the times of the various medical assessments to be performed on the participant (e.g., take vital signs five minutes after administering the drug). Also, the clinical protocol document generally includes a section that provides a text description of the same information contained in the drug administration and activity chart. Thus, any revision to the drug administration and activity chart typically requires a corresponding revision in the section providing the text description of the chart.
The development of a clinical protocol document is typically performed manually using a word processing application. A drug manufacturer may test many drugs each year, thereby requiring many clinical protocols be developed. Thus, the development of a clinical protocol document for a clinical trial is generally a very time consuming, manually intensive procedure. As such, improvements are needed to assist in the production of such documents.